Epidemiologic data are accumulating which show that the human papillomavirus (HPV) is strongly associated, as a factor or co-factor, with cervical cytologic abnormalities, such as cervical intraepithelial neoplasias (CIN) and carcinoma in situ (CIS). Syrjanen, K. J., In: Papillomaviruses and Human Disease, K. Syrjanen, L. Gissman, and L. G. Koss (Eds.), Springer-Verlag, pp 467-503, (1987). In general, these dysplasias are found in the transition zone of the cervix and are graded from mild to severe (I to III), based on the extent to which neoplastic cells extend from the basal layer to the epithelial surface. Complete replacement of the epithelium by neoplastic cells is termed carcinoma in situ (CIS).
At least 60 types of HPV, isolated from various parts of the human body, have been documented, and more than 20 of these types have been shown to be associated with the genital mucosa. E. M. de Villiers, J. Virol., 63(11):4898-4903 (1989). Although present information strongly supports the close association between HPV and cervical neoplasia, and shows that many individuals clearly have HPV DNA (i.e., infections), transiently and/or latently, it also makes it clear that women in whom HPV is present in cervical cells do not always progress to more serious dysplasia. Syrjanen et al. in Cancer Cells, Vol. 5, Cold Spring Harbor, pp. 281-288 (1987); deBrux et al., Bull. Cancer (Paris), 70:410-422 (1983); Mitchell et al., The Lancet, 1:573-575 (1986). Thus, simple detection of HPV DNA in cervical specimens lacks discriminatory predictive value for identification of women at risk for serious disease. A method for assessing HPV activity which can be used to predict progression to serious CIN or CIS is needed.